Plant Process C&Q Engineer - GMP Packaging & Filling

Sanofi Group; Pennsylvania; Hybrid; USD 86,000 - 124,000; Full time

Job summary

Sanofi in Swiftwater, PA, seeks a Plant Process Commissioning Qualification Engineer to govern and execute commissioning and qualification activities across OPEX and CAPEX projects. You will ensure adherence to procedures, test scripts, and data packs for packaging and inspection systems.

You will collaborate with project teams, drive quality governance, manage changes, and support audits to protect product integrity and patient safety in vaccine and pharmaceutical operations.

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Computer sciences or other related technical fields.
• 5+ years of experience in Commissioning, Qualification, Testing Equipment, quality assurance, Engineering, Packaging or related fields.
• Experience with commissioning and qualification methods in pharma/manufacturing contexts.

Responsibilities

• Review and approval of SAT FAT Commissioning and Qualification documentation, design protocols, test scripts and reports.
• Audit engineering quality and ensure alignment with site and project level CQ plans and guidelines.
• Authoring protocols, test scripts and data packs; supporting change controls and deviations as needed.
• Provide interface with project management, controls functions, and contractor management to ensure schedule and budget adherence.

Skills

Commissioning governance

Qualification testing

Cross-functional collaboration

Documentation review

Quality systems

Education

Bachelor’s degree in Engineering or life sciences

Job description

Sanofi in Swiftwater, PA, seeks a Plant Process Commissioning Qualification Engineer to govern and execute commissioning and qualification activities across OPEX and CAPEX projects. You will ensure adherence to procedures, test scripts, and data packs for packaging and inspection systems.

You will collaborate with project teams, drive quality governance, manage changes, and support audits to protect product integrity and patient safety in vaccine and pharmaceutical operations.